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CAVHANZA™ (nilotinib) Orally Disintegrating Tablets (ODT)

What is CAVHANZA?

CAVHANZA is a prescription medicine used to treat:1

  • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
  • Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy.

CAVHANZA can be taken with proton pump inhibitors (e.g. esomeprazole) and H2 receptor antagonists (e.g. famotidine). It comes as an orally disintegrating tablet (ODT), with no mealtime restrictions, offering convenience and flexibility.1

At Cycle Pharmaceuticals, we understand the importance of providing product support that complements treatment for patients living with a rare oncological disease. That’s why we created Cycle Vita™, delivering individualized product support* at every step.

CAVHANZA™ (nilotinib) Orally Disintegrating Tablets (ODT) Logo

Find out more about CAVHANZA

Support available to you with CAVHANZA

Download and print the enrollment form, share it with your doctor and discuss why you think CAVHANZA may be suited to your needs.

Enroll here

The first steps

Your Cycle Vita team will quickly get to work with your insurance provider to help you understand your coverage.

If prior authorization is needed, our experienced team will work with your insurance provider to understand the requirements and assist your healthcare provider to ensure documentation and requirements are met.

We will route your CAVHANZA therapy to the appropriate specialty pharmacy and follow-up to ensure swift shipment of your medication.

Additional assistance, when required, throughout your journey

In some cases, an appeal for insurance coverage may be needed. Where this is the case, our experienced team will work with your insurance and healthcare providers to understand the requirements and help you with any CAVHANZA reimbursement gaps.

If you have commercial insurance, you may be eligible for the Co-Pay Assistance Program. Commercially insured eligible patients may pay as little as $0.

Please contact us to find out more about this and other programs that may be available to you.

We provide product support to help you manage every aspect of your CAVHANZA therapeutic routine, such as onboarding onto therapy and clinical education.

Translation services are available on request.

What is Ph+ CML?

Ph+ CML is a rare type of leukemia driven by an abnormality called the Philadelphia chromosome. The Philadelphia chromosome is an error in the DNA that occurs when parts of chromosome 9 and chromosome 22 swap places. This creates a fusion gene called BCR::ABL1, which produces a protein that leads to uncontrolled growth of leukemia cells (cancer).2

If symptoms do occur, they may include fatigue, weakness, night sweats, itchiness, abdominal or bone pain, easy bleeding or bruising, anemia, loss of appetite, feeling full after small meals, and unexplained weight loss.3

Ph+ CML is often diagnosed after a routine blood test shows a high white blood cell count.3 Other tests to help confirm a diagnosis may include; a blood chemistry study, bone marrow aspiration and biopsy, cytogenetic analysis, fluorescence in situ hybridization (FISH) and a reverse transcription-polymerase chain reaction test (RT-PCR).4

Resources

Resource IconFull Prescribing Information
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Resource IconPHI Form
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Resource IconEnrollment Form
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Resource IconPatient Initiation Brochure
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Footnote
*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.

CAVHANZA™ is a trademark of Flex Pharma.

References

  1. CAVHANZA™ (nilotinib) Orally Disintegrating Tablets. Prescribing Information. Flex Pharma.
  2. Leukemia and Lymphoma Society. Ph-Positive ALL Therapy | Leukemia and Lymphoma Society. [online] Available at: https://www.lls.org/leukemia/acute-lymphoblastic-leukemia/treatment/ph-positive-all-therapy. [Accessed: June 12 2025].
  3. Medical News Today. (2025). What is Philadelphia chromosome-positive chronic myeloid leukemia? [online]. Available at: https://www.medicalnewstoday.com/articles/philadelphia-chromosome-positive-chronic-myeloid-leukemia#symptoms [Accessed: June 12 2025].
  4. National Cancer Institute. (2025). Chronic Myeloid Leukemia Treatment (PDQ®) – Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cml-treatment-pdq#_1 [Accessed: June 12 2025].
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Indication and Important Safety Information: CAVHANZA™ (nilotinib) Orally Disintegrating Tablets

Indications

CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of:

  • Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
  • Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy.


Contraindications

Do not take CAVHANZA if you have:

  • low levels of potassium or magnesium in your blood.
  • long QT syndrome.


Important Safety Information

Warning: QT Prolongation and Sudden Deaths

  • Nilotinib can cause changes in heart rhythm. Before starting and during treatment, your healthcare provider will check your potassium and magnesium levels and take steps to resolve any problems you may have. Your heart will be monitored with ECG tests at the start, after 7 days, regularly during treatment, and after any changes in dosage.
  • Sudden deaths have happened in people taking nilotinib. Do not take CAVHANZA if you have low potassium, low magnesium, or a heart rhythm disorder called long QT syndrome.
  • Avoid taking CAVHANZA with other medicines that can affect your heart rhythm or strong medicines that affect how nilotinib works.

Warnings and Precautions:

  • Different Nilotinib Products and Risk of Medication Errors: CAVHANZA is not the same as other nilotinib products. The amount of nilotinib in a dose of CAVHANZA may not be the same as the amount in other products containing nilotinib. Do not switch from CAVHANZA to other medicines that contain nilotinib without talking to your healthcare provider.
  • Low Blood Counts: CAVHANZA may cause your blood counts to drop, including low levels of white blood cells, red blood cells, or platelets. Your healthcare provider will check your blood counts regularly while you are taking CAVHANZA. If your blood counts change too much, your treatment may be temporarily stopped, or your dose may be lowered.
  • Heart and Blood Vessel problems: Heart and blood vessel problems, including blocked arteries, have been reported in patients newly diagnosed with Chronic Myeloid Leukemia (CML). Your healthcare provider will check your heart and blood vessel health before and during treatment. Risk factors will be monitored and treated as needed while you take CAVHANZA.
  • Pancreatitis Risk: CAVHANZA can cause an increase in a blood enzyme called lipase. If you have had pancreatitis before, you may be more susceptible to higher lipase levels. Your healthcare provider will monitor certain blood tests related to the pancreas while you are taking CAVHANZA. If you develop stomach pains alongside abnormal test results, your treatment may be paused, and further tests may be required to check for pancreatic inflammation.
  • Liver Problems: CAVHANZA may cause liver problems, shown by increases in certain tests (bilirubin, AST, ALT, and alkaline phosphatase). Your healthcare provider will check your liver function with blood tests regularly, usually once a month, or more often if needed, while you are taking CAVHANZA.
  • Electrolyte Abnormalities: CAVHANZA can affect the levels of some minerals (electrolytes) in your blood, such as phosphate, potassium, calcium, and sodium. These levels will be checked and corrected before you start treatment and monitored regularly while you are taking CAVHANZA.
  • Tumor Lysis Syndrome: Some patients treated with nilotinib for resistant or intolerant CML have developed tumor lysis syndrome (TLS). It is important to stay well hydrated. Your healthcare provider may do a blood test to check your uric acid levels are in normal range and offer treatment if required, to help reduce the risk of side effects when treatment begins.
  • Bleeding: Bleeding can happen while taking this medicine. Tell your healthcare provider right away if you notice any signs of bleeding. Your healthcare provider may check your blood, adjust your treatment and provide care to manage bleeding.
  • Fluid Retention: Tell your healthcare provider right away if you notice any sudden weight gain, swelling (such as in your legs or ankles), or shortness of breath while taking CAVHANZA. These symptoms will be checked and treated by your healthcare provider if necessary.
  • Effects on Growth and Development in Pediatric Patients: Nilotinib may slow growth and development in children. Growth changes, such as height and weight, may occur during treatment.
  • Pregnancy Risks: CAVHANZA can harm an unborn baby. If you can become pregnant, talk to your healthcare provider about this risk and use effective birth control during treatment with CAVHANZA.
  • Treatment Discontinuation: Before stopping treatment, patients must have a specific type of leukemia marker (BCR‐ABL) that can be accurately measured. A specially approved lab test that is very sensitive must be used to confirm eligibility. If your treatment is stopped, your healthcare provider will arrange regular blood tests with the same approved test to closely monitor you and make sure the disease does not return.

Adverse Reactions:

  • Heart rhythm problems have occurred with this medicine, including a condition called QT prolongation, which can be serious and may lead to sudden death. Your healthcare provider may check your heart function and electrolytes before and during treatment.
  • Serious side effects have been reported, including severe infections, bleeding in the brain, and significant drops in blood cell counts.
  • The most common side effects seen in studies were skin rash or itching, headache, nausea, feeling tired, hair thinning or hair loss, muscle pain, stomach pain, constipation, diarrhea, and vomiting.
  • Changes in blood counts can occur. CAVHANZA may lower the number of platelets, white blood cells, or red blood cells, which can increase the risk of bleeding, infections, or anemia. Your healthcare provider will monitor your blood counts during treatment.
  • Some patients stopped treatment because of side effects.
  • Additional side effects have been reported after the medicine became available, including damage to small blood vessels, facial weakness or paralysis, and bone damage (osteonecrosis).

Drug Interactions:

Medicines and foods that strongly affect liver enzymes (CYP3A inhibitors), such as grapefruit or grapefruit juice, should be avoided while taking CAVHANZA. If they cannot be avoided, your healthcare provider may lower your dose. Certain medicines and foods can increase the amount of nilotinib in your body and raise the risk of side effects.

Medicines that strongly increase liver enzyme activity (CYP3A inducers) should also be avoided while taking CAVHANZA. These medicines can lower the amount of nilotinib in your body and may reduce how well the treatment works.

Medicines that can affect heart rhythm (QT‐prolonging drugs), should not be taken with CAVHANZA, as using them together may increase the risk of abnormal heartbeats. Always tell your healthcare provider about all medicines you take.

Use in Specific Populations:

Pregnancy: There is limited information about the use of this medicine during pregnancy. Effects on an unborn baby are not fully known and taking this medicine may pose a risk to the fetus. If you are pregnant or think you may be pregnant, talk to your healthcare provider right away.

Lactation: It is not known whether nilotinib passes into human breast milk or if it could affect a breastfed baby. This medicine may cause serious side effects in a breastfed child, women should not breastfeed during treatment with CAVHANZA and for 14 days after the last dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Pediatric use: CAVHANZA is not approved for use in children. Slowed growth has been reported in children taking nilotinib.

Additional pediatric use information is approved for Novartis Pharmaceuticals Corporation’s TASIGNA (nilotinib) capsules. However, due to Novartis Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Geriatric use: No major differences for safety were observed in patients ≥65 years whilst taking CAVHANZA.

For more detailed information, please refer to the full Prescribing Information at cavhanza.com/pi/.

To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

Warning: QT Prolongation and Sudden Deaths

  • Nilotinib can cause changes in heart rhythm. Before starting and during treatment, your healthcare provider will check your potassium and magnesium levels and take steps to resolve any problems you may have. Your heart will be monitored with ECG tests at the start, after 7 days, regularly during treatment, and after any changes in dosage.